Reactor surface finish remediation

Abstract

Improved biopharmaceutical processing equipment such as reactor vessels and stainless steel surfaces, and methods of determining the same are disclosed herein. In some embodiments, a biopharmaceutical processing equipment can include a vessel having a surface that is configured to contact proteinaceous processing material, wherein the surface has a pre-commissioning surface roughness of greater than about 20 Ra Max (μin).

What is claimed is: 
     
       1. A biopharmaceutical processing equipment, comprising:
 a vessel defining a volume for receiving a proteinaceous processing material, the vessel having an interior reactor surface that is configured to contact proteinaceous processing material when contained within the volume of the vessel, the biopharmaceutical processing equipment further comprising a clean-in-place (CIP) apparatus configured to clean the surface, and wherein the interior reactor surface is made from stainless steel and has a pre-commissioning surface roughness of greater than or equal to about 25 Ra Max (μin) and less than or equal to about 250 Ra Max (μin); 
 a nutrient inlet for feeding a nutrient to a proteinaceous processing material contained in the vessel volume; 
 an outlet for removing a proteinaceous processing material from the vessel; 
 a pH sensor for monitoring a pH level in the vessel; and 
 a gas sensor for monitoring a dissolved gas in a proteinaceous processing material contained in the vessel volume. 
 
     
     
       2. The biopharmaceutical processing equipment of  claim 1 , wherein the surface has a pre-commissioning surface roughness of greater than about 35 Ra Max (μin) and less than or equal to about 250 Ra Max (μin). 
     
     
       3. The biopharmaceutical processing equipment of  claim 1 , wherein the surface has a pre-commissioning surface roughness of greater than about 90 Ra Max (μin) and less than or equal to about 150 Ra Max (μin). 
     
     
       4. The biopharmaceutical processing equipment of  claim 1 , wherein the surface has a pre-commissioning surface roughness of about 150 Ra Max (μin). 
     
     
       5. The biopharmaceutical processing equipment of  claim 1 , wherein the surface is formed of 316L stainless steel. 
     
     
       6. The biopharmaceutical processing equipment of  claim 1 , wherein the gas sensor is configured to monitor dissolved oxygen or dissolved carbon dioxide. 
     
     
       7. A biopharmaceutical processing equipment, comprising:
 a vessel defining a volume for receiving a proteinaceous processing material, the vessel having an interior reactor surface that is configured to contact proteinaceous processing material when contained within the volume of the vessel, and wherein the interior reactor surface is made from stainless steel and has a thickness of greater than 2.6 mm, and wherein the surface has a surface finish that is free of a surface anomaly that exceeds a maximum depth of surface pitting of about 2.6 mm; 
 a nutrient inlet for feeding a nutrient to a proteinaceous processing material contained in the vessel volume; 
 an outlet for removing a proteinaceous processing material from the vessel; 
 a pH sensor for monitoring a pH level in the vessel; and 
 a gas sensor for monitoring a dissolved gas in a proteinaceous processing material contained in the vessel volume. 
 
     
     
       8. The biopharmaceutical processing equipment of  claim 7 , wherein the processing equipment surface is free of a surface anomaly that exceeds a maximum scratch depth of about 1.0 mm. 
     
     
       9. The biopharmaceutical processing equipment of  claim 7 , wherein the surface is free of a surface anomaly that exceeds a maximum depth of surface pitting of about 1.2 mm. 
     
     
       10. The biopharmaceutical processing equipment of  claim 7 , wherein the surface is formed of 316L stainless steel. 
     
     
       11. The biopharmaceutical processing equipment of  claim 7 , wherein the surface has a pre-commissioning surface roughness of greater than about 20 Ra Max (μin). 
     
     
       12. The biopharmaceutical processing equipment of  claim 7 , wherein the surface has a pre-commissioning surface roughness of greater than about 35 Ra and less than or equal to about 250 Ra Max (μin). 
     
     
       13. The biopharmaceutical processing equipment of  claim 7 , wherein the surface has a pre-commissioning surface roughness of about 150 Ra Max (μin). 
     
     
       14. The biopharmaceutical processing equipment of  claim 7 , wherein the surface has a surface finish that is free of a surface anomaly that exceeds any of: a maximum depth of surface pitting of about 1.2 mm, and a maximum scratch depth of about 1.0 mm. 
     
     
       15. The biopharmaceutical processing equipment of  claim 7 , wherein the gas sensor is configured to monitor dissolved oxygen or dissolved carbon dioxide. 
     
     
       16. A biopharmaceutical processing equipment, comprising:
 a vessel defining a volume for receiving a proteinaceous processing material, the vessel having an interior reactor surface that is configured to contact proteinaceous processing material when contained within the volume of the vessel, and wherein the interior reactor surface is made from stainless steel and has a pre-commissioning surface roughness of greater than or equal to about 40 Ra Max (μin) and less than or equal to about 250 Ra Max (μin); 
 a nutrient inlet for feeding a nutrient to a proteinaceous processing material contained in the vessel volume; 
 an outlet for removing a proteinaceous processing material from the vessel; 
 a pH sensor for monitoring a pH level in the vessel; and 
 a gas sensor for monitoring a dissolved gas in a proteinaceous processing material contained in the vessel volume. 
 
     
     
       17. The biopharmaceutical processing equipment of  claim 16 , wherein the gas sensor is configured to monitor dissolved oxygen or dissolved carbon dioxide.